Welcome to our dedicated page for Y-Mabs Therapeutics news (Ticker: YMAB), a resource for investors and traders seeking the latest updates and insights on Y-Mabs Therapeutics stock.
Y-mAbs Therapeutics, Inc. (YMAB) generates news that spans commercial oncology performance, clinical development milestones in radioimmunotherapy, and significant corporate transactions. Company announcements consistently describe Y-mAbs as a commercial-stage biopharmaceutical company focused on novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, with its lead commercial asset DANYELZA® (naxitamab-gqgk) for relapsed or refractory high-risk neuroblastoma.
News coverage for Y-mAbs frequently highlights financial results and segment updates, including quarterly revenue from DANYELZA, ex-U.S. distribution trends, and the allocation of resources between the DANYELZA and Radiopharmaceuticals business units. Earnings releases often discuss cost of goods sold, research and development spending, selling, general, and administrative expenses, and net loss, along with management commentary on operating strategy and capital efficiency.
Another major category of YMAB news involves clinical and R&D developments in the company’s SADA Pretargeted Radioimmunotherapy (PRIT) platform. Press releases describe progress in the GD2-SADA Phase 1 Trial 1001 in GD2-expressing solid tumors, including pharmacokinetic and dosimetry data, and the initiation of the CD38-SADA Phase 1 Trial 1201 in relapsed or refractory non-Hodgkin lymphoma. Y-mAbs also reports on preclinical pharmacokinetic modeling, optimization of radiohaptens such as “Proteus,” and expansion of its radiopharmaceutical pipeline into additional oncology franchises.
Y-mAbs news also covers regulatory and guideline recognition, such as the inclusion of naxitamab-gqgk (DANYELZA) as a Category 2A treatment option in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma. These updates provide context on how DANYELZA is positioned within clinical practice for high-risk neuroblastoma.
A key theme in recent YMAB headlines is corporate transformation and acquisition activity. In August 2025, Y-mAbs announced that SERB Pharmaceuticals, through an affiliate, agreed to acquire the company in an all-cash transaction at $8.60 per share, with an equity value of approximately $412 million, as described in joint press releases and Form 8-K filings. Subsequent news and SEC filings report the commencement and completion of the tender offer, the closing of the merger, and the resulting delisting of Y-mAbs common stock from the Nasdaq Global Select Market.
Investors and observers following YMAB-related news can expect updates on quarterly financial performance, DANYELZA commercial metrics, clinical trial progress for SADA-based programs, radiopharmaceutical R&D strategy, and the implications of the company’s acquisition by an affiliate of SERB Pharmaceuticals. This news flow provides insight into both the historical public-company phase of Y-mAbs and its transition into a privately held subsidiary within a larger specialty pharmaceutical group.
Y-mAbs Therapeutics announced that the FDA granted Rare Pediatric Disease Designation for its 177Lu-omburtamab-DTPA antibody program aimed at treating medulloblastoma. This designation allows eligibility for a Priority Review Voucher upon potential approval of the biologics license application. The company is advancing this program through Phase 1 clinical trials for both pediatric and adult patients with B7-H3 positive tumors. Y-mAbs now has four compounds with RPDD, highlighting its commitment to addressing unmet medical needs in rare pediatric cancers.
Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) announced the acceptance of two presentations at the International Society of Pediatric Oncology Virtual Annual Congress from October 21-24, 2021. The oral presentation will focus on DANYELZA® for treating high-risk neuroblastoma, while a poster will detail omburtamab for CNS metastasis treatment. Both products are licensed from Memorial Sloan Kettering. DANYELZA is approved for pediatric patients and carries a Boxed Warning for serious side effects. Y-mAbs is advancing its pipeline targeting GD2 and B7-H3 tumor-associated markers.
Y-mAbs Therapeutics announced that its partner SciClone Pharmaceuticals received priority review for the Biologics License Application (BLA) of DANYELZA® (naxitamab-gqgk) for treating high-risk neuroblastoma in China. This priority review aims to expedite the approval process, with potential launch expected by Q1 2022. DANYELZA was recently administered to its first patient in China, marking a significant milestone for the company.
Y-mAbs Therapeutics announced a key opinion leader webinar on DANYELZA data for high-risk neuroblastoma on September 23, 2021. The event will feature experts Jaume Mora and Shakeel Modak presenting frontline and HITS data, respectively. Company leaders Thomas Gad, Steen Lisby, and Claus J. Moller will offer updates on the pipeline and corporate strategy. DANYELZA is FDA-approved for treating high-risk neuroblastoma in pediatric and adult patients. Registration is available here.
Y-mAbs Therapeutics (Nasdaq: YMAB) reported its Q2 2021 financial results, highlighting a net loss of $22.9 million, or ($0.53) per share, a reduction from the $40.4 million loss in Q2 2020. Revenues totaled $11.0 million, driven by $9.0 million from DANYELZA sales. The company had a cash balance of $233.6 million at the end of the quarter, significantly up from $114.6 million at the end of 2020. Y-mAbs is progressing with multiple regulatory submissions, including an accepted BLA submission for DANYELZA in China and an anticipated BLA resubmission for omburtamab by year-end.
Y-mAbs Therapeutics (Nasdaq: YMAB) will report its financial results for Q2 2021 on August 5, 2021, post-market close. This will be followed by a conference call on August 6, 2021, at 9 a.m. ET. Key participants include founder Thomas Gad, CEO Dr. Claus Moller, and CFO Bo Kruse. The company focuses on innovative antibody-based cancer therapies and has an FDA-approved product, DANYELZA, along with a pivotal-stage candidate, omburtamab.
Y-mAbs Therapeutics (NASDAQ: YMAB) announced that SciClone Pharmaceuticals has submitted a Biologics License Application (BLA) for DANYELZA® (naxitamab-gqgk) to China's National Medical Products Administration (NMPA) for treating relapsed/refractory high-risk neuroblastoma. This submission follows FDA approval within just seven months, indicating rapid progress in making the innovative therapy available to pediatric patients in China. Y-mAbs emphasizes the strategic collaboration with SciClone to ensure timely market entry if approved.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced a positive opinion from the EMA's Committee for Orphan Medicinal Products for 177Lu-omburtamab-DTPA, targeting medulloblastoma. This recommendation supports orphan drug designation, expected to be granted by the European Commission within 30 days. The designation will provide development incentives and 10 years of market exclusivity upon approval, enhancing Y-mAbs' European expansion plans. The company aims to improve treatment options for patients with this rare and life-threatening condition.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced the conclusion of a Type B meeting with the FDA regarding its drug omburtamab for treating pediatric neuroblastoma patients with CNS/metastatic conditions. The company believes it gained clarity on resubmitting the Biologics License Application (BLA) after discussing statistical analysis plans. Y-mAbs plans to provide additional data to the FDA in Q3 2021 and aims for a rolling BLA resubmission by year-end. The approval of omburtamab could fulfill an unmet medical need in pediatric oncology.
Y-mAbs Therapeutics, focused on innovative cancer treatments, announced the presentation of three-year follow-up data for DANYELZA and GM-CSF in high-risk neuroblastoma patients at the ASCO Virtual Annual Meeting on June 4, 2021. The study included 73 patients, showing a three-year event-free survival of 74% for first complete remission and 19% for later remissions. Overall survival rates were 92% and 66%, respectively. The positive data suggests DANYELZA's potential to differentiate itself from existing therapies if approved.